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MicroScan

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name: MicroScan FDA UDI
Generic Name: General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name: Neg MIC Panel Type 43 FDA UDI
Model / Reference: B1017-420 FDA UDI
Description: Neg MIC Panel Type 43 FDA UDI

Identifiers

Primary DI / UDI-DI: 15099590657956 FDA UDI
510(k) Number: K010418 FDA UDI
K020037 FDA UDI
K032706 FDA UDI
K050585 FDA UDI
K061536 FDA UDI
K083262 FDA UDI
K192355 FDA UDI
K201423 FDA UDI
K202343 FDA UDI
K862140 FDA UDI
K863776 FDA UDI
K870074 FDA UDI
K874876 FDA UDI
K883076 FDA UDI
K926545 FDA UDI
K955910 FDA UDI
K962150 FDA UDI
K970676 FDA UDI
K971376 FDA UDI
FDA Product Code: LTW FDA UDI
LTT FDA UDI
LRG FDA UDI
JWY FDA UDI
GMDN Term: General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K010418 also covers:

MicroScan — Beckman Coulter, Inc.
MicroScan — Beckman Coulter, Inc.

K020037 also covers:

MicroScan — Beckman Coulter, Inc.

K032706 also covers:

MicroScan — Beckman Coulter, Inc.

K061536 also covers:

MicroScan — Beckman Coulter, Inc.

K083262 also covers:

MicroScan — Beckman Coulter, Inc.
MicroScan — Beckman Coulter, Inc.

K192355 also covers:

MicroScan — Beckman Coulter, Inc.

K201423 also covers:

MicroScan — Beckman Coulter, Inc.

K202343 also covers:

MicroScan — Beckman Coulter, Inc.

K862140 also covers:

K863776 also covers:

K870074 also covers:

K874876 also covers:

K883076 also covers:

K926545 also covers:

MicroScan — Beckman Coulter, Inc.

K955910 also covers:

MicroScan — Beckman Coulter, Inc.
MicroScan — Beckman Coulter, Inc.

K962150 also covers:

K970676 also covers:

MicroScan — Beckman Coulter, Inc.
MicroScan — Beckman Coulter, Inc.

K971376 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Beckman Coulter, Inc.

Sources (1)

FDA UDI 0f1c3c3d-f490-4f88-811b-0fa2ac5ce1a4 34 fields · synced Jun 8, 2026